Observational Prospective Study on Patients Treated With Norditropin® - Full Text View

Sponsor:	Novo Nordisk
Information provided by (Responsible Party):	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00960128

Purpose

This study is conducted globally. The aim of this observational study is to investigate the effectiveness and safety of real-life treatment with Norditropin®. The study population will consist of children and adults who are on treatment with Norditropin® in accordance with normal clinical practice.

Condition	Intervention
Growth Hormone Deficiency (GHD) Growth Hormone Deficiency, Adults (GHDA) Turner Syndrome Small for Gestational Age (SGA) Chronic Renal Insufficiency Noonan Syndrome	Drug: somatropin

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	NordiNet® International Outcome Study-Observational Prospective Study on Patients Treated With Norditropin®

Resource links provided by NLM:

Genetics Home Reference related topics: 17q21.31 microdeletion syndrome Baller-Gerold syndrome combined pituitary hormone deficiency Crouzon syndrome Noonan syndrome persistent Müllerian duct syndrome pseudoachondroplasia tetrasomy 18p Turner syndrome

MedlinePlus related topics: Kidney Failure Turner Syndrome

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Effect of Norditropin® treatment on height gain (change in height) in children [ Time Frame: Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study. ] [ Designated as safety issue: No ]
Effect of Norditropin® treatment on body weight and body composition in adults [ Time Frame: Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Effect of Norditropin® treatment body weight, blood biochemistry, bone age, the endocrine system and pubertal development in children [ Time Frame: Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study. ] [ Designated as safety issue: Yes ]
Effect of Norditropin® treatment on quality of life, blood biochemistry and the endocrine system in adults [ Time Frame: Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	17000
Study Start Date:	April 2006
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A Adult cohort	Drug: somatropin The effectiveness and safety data collection with the use of Norditropin® in daily clinical practice with adults.
B Paediatric cohort	Drug: somatropin The effectiveness and safety data collection with the use of Norditropin® in daily clinical practice with children.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The study population consists of children and adults who are on treatment with Norditropin® in accordance with normal clinical practice

Criteria

Inclusion Criteria:

Judged by the physician as per the Norditropin® label

Exclusion Criteria:

Judged by the physician as per the Norditropin® label

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00960128

Show 18 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Viatcheslav Rakov, MD

Novo Nordisk Health Care AG

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00960128 History of Changes
Other Study ID Numbers:	GHLIQUID-3676
Study First Received:	August 13, 2009
Last Updated:	January 24, 2012
Health Authority:	Czech Republic: Not required for observational study; Denmark: Not required for observational study; Finland: Not required for observational study; France: Not required for observational study; Germany: Not required for observational study; Hungary: Not required for observational study; Italy: Not required for observational study; Lithuania: Not required for observational study; Norway: Not required for observational study; Russia: Not required for observational study; Serbia: Not required for observational study; Slovenia: Not required for observational study; Sweden: Not required for observational study; Switzerland: Not required for observational study; United Kingdom: Not required for observational study; Brazil: Not required for observational study; Ireland: Not required for observational study; Israel: Ministry of Health

Additional relevant MeSH terms:

Dwarfism, Pituitary
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Noonan Syndrome
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Endocrine System Diseases
Renal Insufficiency
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism

Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Kidney Diseases
Urologic Diseases
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Connective Tissue Diseases

ClinicalTrials.gov processed this record on February 09, 2012